Job Description Our client is looking for a QA Validation consultant to join their team in Dundalk.
Based within the QA department, they will be responsible for providing Quality oversight for engineering and validation related activities.
They will ensure the timely review/approval of documentation and resolution of any internal/external quality issues relating to the associated project in accordance with Site procedures.
Key Responsibilities Quality review and approval of qualification/validation documentation and associated data for conformance to regulations, Standard Operating Procedures (SOPs), specifications and other applicable acceptance criteria.
Review and approve validation lifecycle documentation, including URS, specification documents, Test Protocols/Reports, risk assessments, data integrity risk assessments, traceability matrices.
Participate in event/deviation investigation and change evaluation relating to engineering, validation and computerized systems.
Participate in software, equipment and instrument qualification where necessary.
Provide Quality oversight of processes and procedures related to DI, Computerised Systems Automation compliance.
Provide Quality support for Electronic Data Review and Data Management.
Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
Assist in implementation of global standards and procedures into the site Quality Systems.
Participate in other projects/duties as assigned.
Flexibility to take on additional tasks and responsibilities at the discretion of the QAV Lead Key Requirements Thorough knowledge of GxP regulations (e.g. EU-GMP, FDA, ISO, GAMP).
Academic degree in Computer systems, Engineering or Natural/Applied Sciences (e.g. Chemistry, Pharmacy, Biology, Biotechnology, Engineering, IT).
Robust experience (+5 years) in a Quality Engineering / Validation role for Biologics, medical device or pharmaceutical manufacturing.
Demonstrated experience in change control and deviation management Demonstrated experience in equipment / facility / utility qualification and computerised system validation.
Solid Understanding of principles of New Product Introduction, Shipping Validation, Cleaning Validation and Process Validation.
Ability to operate across functional boundaries, both internal and external Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration Prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
Minimum of 5 years recent experience in QA Validation focused roles, including Qualification of low-medium complexity analytical equipment (benchtop) Experience with clean utilities / clean rooms is not the priority, even though it's listed in the spec QA compliance experience, less focus on execution tasks Willingness / ability to be full-time on site.
Clear communicator Benefits Competitive and attractive employee compensation package Pension contributions Health insurance Paid holidays Location: Dundalk, Ireland | on-site